This phase III clinical trial will study which type of external radiation treatment for prostate cancer has a better side effect profile: IMRT or Proton Therapy.
The details
IMRT (or Intensity-modulated radiation therapy) is a type of radiation therapy commonly used to treat prostate cancer. It uses x-ray beams to target the prostate tumor and destroy it. By using X-rays shot from different angles, most of the radiation can be focused on single point in the body. This allows more protection of normal healthy tissue surrounding the tumor compared to other types of radiation therapy.
Proton Beam Therapy (or PBT) is another type of external radiation therapy. It is also an approved treatment for prostate cancer, although less commonly used. Protons are tiny particles that can be controlled to travel a certain distance and stop. This allows proton therapy to be as precise as IMRT. It simply uses a different type of radiation.
Both IMRT and proton therapy are thought to be equally effective in treating prostate cancer. By better focusing the radiation on the prostate, these two methods generally have fewer side effects compared to standard radiation treatment.
In this research study, researchers are comparing IMRT to PBT to determine which therapy best minimizes the side effects of radiation treatment.
Who are they looking for?
This study is looking for people who have been diagnosed with adenocarcinoma of the prostate (based on a biopsy) within the last year. Only patients with early stage tumors (T1c to T2b - confined to only one side/lobe of the prostate) will be accepted.
Patients with cancer spread beyond the prostate, who already underwent surgery, radiation therapy or chemotherapy cannot take part in this trial. Patients who received hormone therapy will also be excluded. Other conditions, such as autoimmune diseases (lupus, scleroderma), HIV infection, inflammatory bowel disease and previous hip replacement surgery also represent exclusion criteria.
How will it work
Patients will be randomly divided into two groups:
One group will receive treatment using IMRT
The second group will receive treatment using Proton Beam Therapy
Before you begin radiation therapy you will have a pelvic CT scan in order to design your radiation treatment.
Radiation therapy will be given once a day for 5 days (no weekends or holidays), over the course of 8-9 weeks. During each visit you will be asked questions about your general health and about any problems that you might be having.
After your radiation therapy is complete, follow up visits will check your general health every 3 months for the first year, and every 6-12 months afterwards.
